510(k) Report

Devices descending from K915195

8 later devices reach Enzymun-Test TSH through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961491Elecsys TSH AssayBoehringer Mannheim Corp.19967—
+2K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics201713
+2K130469Liaison TSH, Liaison Control Thyroid 1, Liaison Control Thyroid 2, Liaison Control…DiaSorin, Inc.20130—
+2K062581Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemOlympus America, Inc.20060—
+2K060754Elecsys TSH Calset W/Models 04738551Roche Diagnostics Corp.20061—
+2K962573Elecsys Precicontrol TSHBoehringer Mannheim Corp.19962—
+3K223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.20230—
+3K140534Elecsys Precicontrol TSRoche Diagnostics20140—